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FDA 510(k)

DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT

K-Number: K945613 · 1995-03-06

ApplicantHowmedica Corp.
Decision Date1995-03-06
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K945613. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT?

DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Howmedica Corp.. The 510(k) number is K945613.

When did DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT receive FDA 510(k) clearance?

DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT received FDA 510(k) clearance on 1995-03-06, under 510(k) number K945613.

Who is the listed applicant for DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT?

The FDA product code for DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT is HSX.

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Other records listing Howmedica Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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